(77 days)
2940 nm Er: Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.
2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece. 2940nm Er:YAG is an handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece. Its emission is triggered by means of a footswitch connected to the console of the device it is used with.
The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the "2940 nm Er:Yag Laser Handpiece." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through novel studies.
Therefore, the document does not contain the acceptance criteria and study details that would typically be associated with performance evaluation for a new, innovative device proving clinical effectiveness. Instead, it relies on demonstrating that the new handpiece is sufficiently similar in technology and intended use to existing cleared devices to be considered safe and effective.
Here's a breakdown of why the requested information is not available in the provided text:
- Acceptance Criteria for Performance: The document states, "There are no mandatory performance standards for this device." This means there aren't pre-defined quantitative thresholds (like sensitivity, specificity, or image quality metrics) that the device must meet. The FDA's evaluation for a 510(k) is primarily about substantial equivalence.
- Study Proving Device Meets Acceptance Criteria: Since no specific performance acceptance criteria are defined, there is no corresponding study designed to prove the device meets those criteria in the way one might expect for a diagnostic or novel therapeutic device.
However, the document does contain information about performance data provided in support of the substantial equivalence determination. This includes:
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A table of acceptance criteria and the reported device performance:
Characteristic Acceptance Criteria (Not explicitly stated as such, but rather characteristics for substantial equivalence comparison) Reported Device Performance (2940 nm Er:YAG Laser Handpiece) Safety & EMC Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2 Complies with IEC 60601-1, IEC 60601-2-22 (safety) and IEC 60601-1-2 (EMC) Software V&V Verification and Validation according to FDA Guidance for Software in Medical Devices Successfully underwent verification and validation testing, documentation provided as recommended by FDA guidance. Histological Performance Substantially equivalent skin resurfacing effects to predicate devices with a microlens array. Histological performance data are provided to demonstrate substantially equivalent skin resurfacing effects to its predicate devices with a microlens array. Biocompatibility Established based on predicate devices. Biocompatibility established based on predicate devices. Technological Similarities to Predicates (Various parameters listed in the "Summary of technological similarities and differences" table) See the detailed table below for comparison to primary and additional predicates. Technological Comparison Table from Document (Summarized):
Specifications Subject Device (2940 nm Er:YAG Laser Handpiece) Primary Predicate (Quanta Forte - K152714) Additional Predicate (Fotona F-22/FS-01 Laser Handpiece - K132806) Additional Predicate (MicroSpot Handpiece - K152153) Laser medium Er:YAG Er:YAG Er:YAG Er:YAG Wavelength [nm] 2940 2940 2940 2940 Energy, max [J] 3 3 3 2.5 Fluence [J/cm²] Up to 95 (non-microbeam); Up to 121 (with stacking – microbeam) Up to 95 (non-microbeam) Up to 300 (stacking – microbeam) Up to 51 (stacking – microbeam with 600 µm dots); Up to 150 (stacking – microbeam with 300 µm dots) Pulse duration [ms] 0.3 to 1.5 ms 1 to 1.5 ms 0.1 to 1.5 ms 0.1 - 1.0 ms Repetition rate, max [Hz] 6 5 50 20 Spot size Ø 2, 4, 9mm; Ø 9mm dots array Ø 2, 4, 9mm 13x13 mm dots array 13x13 mm dots array -
Sample size used for the test set and the data provenance: This information is not provided in the document. The document refers to "histological performance data" but does not detail the study design, sample size, or data provenance (e.g., country, retrospective/prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As there's no mention of a clinical "test set" with expert adjudicated ground truth the way you'd find for an AI diagnostic device, these details are absent.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided for the same reasons as point 3.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This type of study is completely irrelevant to the device described (a laser handpiece for dermatological procedures) and is therefore not mentioned or performed. This is not an AI diagnostic device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a surgical laser handpiece; it does not operate as a standalone algorithm. Its performance is directly tied to its physical interaction with tissue under human control. Therefore, this concept is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document mentions "histological performance data" for skin resurfacing effects. This implies that the ground truth for evaluating the laser's effect on tissue would likely be pathology/histology reports or visual assessment of tissue changes, compared to the effects achieved by predicate devices. However, the exact nature of this "ground truth" and how it was established for the comparison is not detailed.
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The sample size for the training set: This device is a physical medical instrument, not an AI model that requires a training set. Therefore, this question is not applicable.
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How the ground truth for the training set was established: This question is not applicable as there is no AI training set for this device.
In summary:
The provided FDA 510(k) document is for a physical medical device (laser handpiece), not an AI diagnostic tool. Therefore, many of the questions related to AI performance metrics, expert adjudication, and training/test sets are not applicable or detailed in this type of submission. The "study" mentioned mainly involves demonstrating compliance with electrical safety, EMC standards, and providing histological data to show comparable effects to predicate devices, thereby establishing substantial equivalence.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.